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Senior Medical Director, Clinical Development
Kyverna TherapeuticsSr. Medical Director engaged in clinical development of cell therapies for autoimmune diseases at Kyverna Therapeutics.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Serve as the physician lead for CAR T-cell therapy clinical trials in autoimmune disease indications, in partnership with internal and external cross-functional teams.
- Oversee medical monitoring of clinical trials, including engagement with site investigators and external medical monitors.
- Partner with clinical operations, biometrics, regulatory, and commercial teams to ensure alignment on strategy and execution.
- Lead design, execution, and interpretation of clinical trials across assigned program
- Provide medical and scientific input into clinical development plans, study protocols, investigator brochures, and regulatory submissions.
- Medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker data.
- Development of clinical trial documents including protocols, ICFs, clinical development plans, and publications.
- Lead the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities.
- Actively engage with external investigators and researchers to identify, evaluate, and support investigator sponsored studies and drive research collaborations.
Requirements
What you’ll need- MD, DO, (or ex-US equivalent) or MD-PhD degree required.
- 7+ years of clinical research experience with 4+ years of industry experience in late phase clinical development involved in the design and execution of clinical trials. Experience in late-stage clinical development preferred.
- Specialty training in neurology, rheumatology, nephrology and/or industry experience in clinical development of cell therapies and/or therapies for autoimmune diseases is highly preferred.
- Proven ability to interpret, discuss and present efficacy and safety data.
- Strong knowledge of GCP/ICH, clinical trial design, clinical development processes, and regulatory requirements.
- Strong ability to communicate and establish effective working relationship with investigators, collaborators, scientific advisors, CROs, and corporate partners.
Benefits
Comp & perks- bonus
- benefits
- participation in Company’s stock plan
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
clinical researchclinical trial designmedical monitoringdata analysissafety data interpretationefficacy data interpretationPK data analysisbiomarker data analysisclinical document developmentregulatory submissions
Soft Skills
communicationcollaborationleadershiprelationship buildingstrategic alignmentscientific inputpresentation skillsengagementteamworkproblem-solving
Certifications
MDDOMD-PhD